Release Details

SAN DIEGO, March 16 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it has commenced a Phase I safety and dose-escalating clinical study with a second compound emanating from Neurocrine's proprietary altered peptide ligand (APL) technology. The clinical study will evaluate the APL compound NBI-6024 in diabetic patients with Type I or Insulin-Dependent Diabetes Mellitus (IDDM) and is designed to assess safety and immune response following the administration of NBI-6024. Neurocrine filed and received approval of a Clinical Trials Certificate (CTX) with the Medicines Control Agency in the United Kingdom for NBI-6024. Based upon successful completion of these trials and with documented safety results, the Company expects to embark on efficacy-based trials in pre-diabetic patients. These trials are expected to evaluate the drug's ability to delay or prevent insulin dependence. In addition, Novartis is currently conducting Phase II studies with Neurocrine's APL (MSP771) for multiple sclerosis (MS).

"Based on the extensive experience in the development of APLs for MS with Novartis, Neurocrine has extended this approach to IDDM. Like MS, IDDM is an autoimmune disease whereby the immune system erroneously identifies healthy tissue as being foreign and mounts an immune response against itself," said Larry Steinman, M.D. Professor, Department of Neurology, Pediatrics, Stanford University School of Medicine and Neurocrine co-founder, who first identified the APL technology.

In the case of IDDM the B-islet pancreatic cells, which are responsible for the production of insulin, are the targets for immune mediated destruction. Working closely with leading Diabetologists, Neurocrine scientists have engineered one of the dominant pancreatic antigens so that it is recognized by the pathogenic immune cell as being foreign. In addition, this APL has been shown in preclinical models to elicit a protective immune response by down regulating the immune-mediated destructive process, thereby preserving the B-islet cell and their insulin producing capability.

In preclinical models, Neurocrine's APL clinical compound also has been shown to reduce the incidence of diabetes. In addition, experiments using immune cells derived from IDDM patients indicate that APLs are recognized by immune cells response to insulin, indicating the APL has the potential to intervene in the disease process in humans. The preclinical data suggest that this therapeutic intervention, if administered prophylactically, may have the potential to prevent the onset of diabetes in those patients who are at high risk, such as first degree relatives of patients with IDDM. In addition, there is the potential to intervene in newly diagnosed patients or patients who still have residual intact B-islet cells function by preventing further destruction, and preserving endogenous insulin production, thereby mitigating disease progression.

According to Jean-Francois Bach, M.D., Professor and Head, Department of Clinical Immunology, Hospital Necker, "New treatments, like the altered peptide ligand (APL) approach may offer great therapeutic potential in the intervention of this devastating autoimmune disease." Dr. Bach is a worldwide leader in clinical autoimmune disease research, who, for numerous years, has investigated the pathogenesis, genetics, prevention and treatment of IDDM.

Diabetes Background

Type 1 or Insulin-Dependent Diabetes Mellitus (IDDM) is an unmet medical condition, characterized by an immune-mediated destruction of the insulin producing beta cells of the pancreatic islet, which represents 5-10% of all diagnosed cases of diabetes. It is estimated that more than one million people in North America and comparable numbers in Europe are afflicted with IDDM. It is one of the most prevalent conditions that strike the pediatric and adolescent populations. It afflicts children of all ages with peak incidences occurring around the ages of 5-7. Current therapies for Type 1 diabetes consist of daily insulin injections to regulate blood glucose levels. There are numerous complications and side effects associated with improper insulin administration and many are life threatening or cause permanent impairment. Insulin, while helping to control glucose levels, has no direct effect on the natural history of disease progression and does not prevent the onset of diabetes. Diabetic patients suffer from a number of related disease complications such as neurological disorders and blindness. Recent advances in the sensitivity of diagnostic tests and the ability to identify pre-diabetic patients allows for a unique opportunity for clinical intervention designed to avert the destruction of the B-islet cells and a lifetime dependence on insulin therapy.

Including NBI-6024, Neurocrine has now advanced five programs into development. The Company's CRF receptor antagonist is currently in Phase II clinical development with its partner, Janssen Pharmaceutica, for anxiety/depression. Neurocrine and its partner, Novartis Pharmaceuticals, are conducting their second Phase II clinical trial with Neurocrine's APL compound in patients with multiple sclerosis. Neurocrine is also conducting a Phase I/II trial with NBI-3001 for glioblastoma (malignant brain tumors) and a Phase Ib trial with NBI-34060 for insomnia.

Neurocrine Biosciences is a leading neuroscience company focused on the discovery and development of novel therapeutics for neuropsychiatric, neuroinflammatory and neurodegenerative diseases and disorders. The Company's neuroscience, endocrine and immunology disciplines provide a unique biological understanding of the molecular interaction between central nervous, immune and endocrine systems for the development of therapeutic interventions for anxiety, depression, Alzheimer's disease, Parkinson's disease, stroke, traumatic brain injury, multiple sclerosis, obesity and diabetes.

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In addition to historical facts, this press release contains forward looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward looking statements are risks and uncertainties associated with Neurocrine's research and development programs and business and finances including, but not limited to, risks and uncertainties associated with, or arising out of, drug discovery, pre-clinical and clinical development of products including risk that research may not generate development candidates, development candidates will not successfully proceed through early clinical trials or that in later stage clinical trials will not show that they are effective in treating humans; determinations by regulatory and governmental authorities; changes in relationships with strategic partners and dependence upon strategic partners for performance of clinical and commercialization activities under collaborative agreements including potential for any collaboration agreement to be terminated without any product success; uncertainties relating to patent protection and intellectual property rights of third parties; impact of competitive products and technological changes; availability of capital and cost of capital; and other material risks. A more complete description of these risks can be found in the Company's Form 10K for the year ended December 31, 1998 and the current form 10Q each of which should be read before making any investment in Neurocrine common stock. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
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